Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD

Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)1,2. Secondary endpoints at year two (96 weeks) reaffirmed superiority of brolucizumab 6 mg in reduction of retinal fluid, an important marker of disease activity in patients with neovascular age-related macular degeneration (nAMD)1,3. Approximately 20 to 25 million people are affected by nAMD, also known as wet AMD, a leading cause of blindness worldwide4,5.

The year two HAWK and HARRIER findings demonstrated that fewer patients with nAMD had intra-retinal fluid (IRF) and/or sub-retinal fluid (SRF) — key markers used by physicians to determine injection frequency in clinical practice — with brolucizumab 6 mg versus aflibercept at week 96 [24% for brolucizumab 6 mg vs. 37% for aflibercept in HAWK (P=0.0001); 24% vs. 39%, respectively, in HARRIER (P<0.0001)]1*.

Additionally, brolucizumab 6 mg patients continued to demonstrate reductions in central subfield thickness (CST) at week 961. An increase in CST in nAMD is an important measure of abnormal fluid accumulation and edema and may result in reduced vision. Absolute reductions in CST from baseline were -175 µm for brolucizumab 6 mg versus -149 µm for aflibercept in HAWK (P=0.0057) and -198 µm versus -155 µm, respectively, in HARRIER (P<0.0001)1*.

Also at week 96, fewer brolucizumab 6 mg patients had sub-retinal pigment epithelium (sub-RPE) fluid (11% for brolucizumab 6 mg vs. 15% for aflibercept in HAWK; 17% vs. 22%, respectively, in HARRIER)1. Additionally, of the patients on brolucizumab 6 mg who successfully completed year one on a 12-week dosing interval, 82% in HAWK and 75% in HARRIER were maintained on a 12-week dosing interval in year two1.

“These findings at year two reaffirm the excellent year one brolucizumab data regarding retinal fluid reduction, a key goal for physicians treating patients with nAMD,” said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of both trials. “These consistent results continue to support brolucizumab as a potential new treatment for patients with nAMD.”